|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648921 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Olanzapine Tablets 5 mg Drug: Zyprexa® Tablets 5 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (5 mg; Mylan) and Zyprexa® Tablets (5 mg; Eli Lilly) in Healthy Volunteers |
| Enrollment: | 30 |
| Study Start Date: | June 2003 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Olanzapine Tablets 5 mg
|
Drug: Olanzapine Tablets 5 mg
5mg, single dose fasting
|
|
Active Comparator: 2
Zyprexa® Tablets 5 mg
|
Drug: Zyprexa® Tablets 5 mg
5mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00648921 History of Changes |
| Other Study ID Numbers: | OLAN-0332 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |